SERBIA Trends and Developments Contributed by: Bisera Andrijašević, BDK Advokati
Legislative Changes Expected new Medicines Act
In recent years, the Serbian government has been working towards positioning the country as a global hub for biotechnology and artificial intel- ligence in healthcare. This strategic focus aims to drive innovation and attract investment in these rapidly evolving fields. On the other hand, these objectives must be supported by legisla- tive changes and regulatory capacities, which are still lagging behind. The process of digitalisa- tion in healthcare is progressing, although there is still much work left ahead. Overview of the Pharmaceutical Market in Serbia The Serbian pharmaceutical market continues to evolve, with total market value reaching EUR1.2 billion in 2022. Healthcare spending accounts for approximately 10% of the country’s GDP, with public funding covering 61% of total healthcare expenditure and out-of-pocket contributions accounting for 39% (data for 2021). Despite ongoing efforts to improve patient access to modern treatments, the availability of innovative therapies remains insufficient. Over the past seven years, 96 new innovative medi- cines have been introduced into the reimburse- ment system. However, as of November 2024, more than 80 innovative medicines were still awaiting inclusion in the positive reimbursement list. A step forward was made in 2024, when 16 new innovative medicines for additional indica- tions were added to the list, but further progress is needed to ensure timely access to cutting- edge treatments for Serbian patients. Following the introduction of the procedure for off-label prescription of medicines in December 2022, in 2023 the Serbian government intro- duced the rules for reimbursements from the Health Insurance Fund for off-label use of medi- cines.
The applicable Medicines and Medical Devices Act was adopted in 2010. As of 1 December 2018, the provisions related to medical devices ceased to apply as the separate Medical Devic- es Act entered into force. A new Medicines Act has been announced several times since 2021, however, despite long-standing discussions, a draft of the new law has yet to be published. The new Medicines Act should additionally align Serbian medicines legislation with EU regula- tions, including the EU Transparency Direc- tive, and introduce clear and shorter deadlines for regulatory procedures. It should eliminate unnecessary administrative barriers, better regu- late pharmaceutical trade, and allow the regis- tration of advanced therapies like gene and stem cell treatments. Provisions on patent protection, pricing mechanisms, and inclusion in the reim- bursement list also need revision to improve and facilitate market access. Improvements in clinical trial regulations, pharmacovigilance, and advertising approval processes are also neces- sary. Amendments to the Medicines Act should also include changes to the regulation of sales chan- nels for over-the-counter (OTC) medicines. Cur- rently, online sales of medicines are prohibited by law, restricting modern access to medications. However, this ban is widely violated through the sale of counterfeit drugs and medicines without marketing authorisation in Serbia, with regulato- ry authorities acting only upon complaints rather than proactively. Additionally, there is no capac- ity for effective oversight of online drug sales, highlighting the need for both regulatory reform and improved monitoring mechanisms.
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